Regulatory Intelligence Director Respiratory & Immunology

We are looking for Regulatory Intelligence Director to join our global teams within Respiratory and Immunology (R&I), at AstraZeneca Biopharmaceuticals R&D.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

We are looking for Regulatory Intelligence Director to join our global teams within Respiratory and Immunology (R&I), at AstraZeneca Biopharmaceuticals R&D. This role can be based in Gothenburg, Sweden, Cambridge, UK, Gaithersburg, US or Durham, US.

The Regulatory Intelligence Director (RID) is responsible for providing disease area specific Regulatory interpretation and impact analysis of emerging competitive intelligence. This is a critical role that will provide curated analysis across a range of regulatory topics and issues to support product teams. The RID will report to the Senior Director for Regulatory Intelligence within the TA Regulatory Affairs group in leading bespoke Regulatory research for RADs including disease and project level Regulatory strategy, due diligence, disease area strategy, initiatives. The RID must possess the ability to assess the impact of key regulatory developments to provide insights that help inform product development strategies. Thus, the RID, must have a strong background in regulatory affairs along with the ability to analyze, summarize, and clearly communicate key regulatory insights.

What You’ll do

The individual in this role will work closely with other Intelligence groups within AZ (Regulatory Policy, Intelligence and Regional Strategy (PIRS), Clinical Information Science, and Global Insights, Analytics, and Commercial Excellence (GIACE). The role will work closely with TA-VP, Executive Regulatory Science Directors, Global Regulatory Leaders (GRLs) and Regulatory Affairs Directors (RADs) to provide the Regulatory Intelligence aspect of disease areas and product-specific Regulatory strategies. The RID will liaise with PIRS on Regulatory policy matters, and lead a coordinated response in providing feedback by obtaining input from key experts and stakeholders in the therapeutic area. The RID will liaise with International, China, and Japan RADs regarding disease area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease. The RID will be responsible for communicating the Regulatory impact and implications of relevant competitive intelligence to stakeholders and senior management within AZ.

  • Conduct analysis and impact assessment of Regulatory Intelligence across the portfolio in a given disease area and communicate findings to key stakeholders and senior leaders within the Company.
  • Provide analysis on EMA, FDA, and/or other global Health Authority trends, perspectives, reports, analyses, activities, etc.
  • Work closely with other Intelligence groups within the company (PIRS, GIACE, Clinical Information Science, etc) to provide the disease area specific Regulatory interpretation and impact.
  • Serve as a central point person within TA in leading bespoke Regulatory research for RADs including project level Regulatory strategy, due diligence, disease area strategy, initiatives etc.
  • Liaise with PIRS in soliciting input and coordinating feedback from key stakeholders in the TA on draft Regulatory guidance documents and Regulatory policies
  • Liaise with International, China, and Japan RADs regarding Disease area-specific guidance and regulatory intelligence aspects in each region, contributing to overall Regulatory landscape per disease
  • Proactively conduct analysis of new drug development and regulatory approaches on e.g. novel clinical trial concepts, RWE, early regulatory access, adaptive/conditional licensing as it relates to the TA
  • Research and analyze Regulatory guidance, precedence, and other asset-specific research projects to support our products and development pipeline per market/region
  • Review relevant EPARs and SBOAs to extract key insights in supporting Regulatory landscaping and strategy
  • Perform research and analysis of relevant Advisory Committee hearings providing pre-meeting briefings and post-meeting impact analysis to key stakeholders and senior leaders within the Company
  • Liaise with Reg Ex/PIRS to support the development and deployment of new technologies, including artificial intelligence, RWE, digital health tools, and novel diagnostics/assays to facilitate regulatory intelligence.

Who you are

We are looking for someone who possesses a broad background of experience working in pharmaceutical business, with prior experience in several areas within global regulatory affairs.

We would also expect you to be experienced in critically reviewing current global regulatory science trends and challenging the latter with a good understanding of the corresponding scientific and clinical components.

Essentials for the role

  • A Bachelor’s degree required. Advanced degree in a science related field and/oother appropriate preferred knowledge/experience. Min of 5 years of relevant exerience
  • Demonstrate competencies of strategic thinking, data and impact analysis.
  • Excellent oral and written communication skills. Ability to develop briefing materials.
  • Ability to work independently and proactively in a fast paced, matrix environment
  • In-depth knowledge of the designated therapeutic area
  • Experience working in drug development including but not limited to, pharmaceutical/biotech industry and government.
  • Ability to synthesize complex and dynamic information into recommendations for colleagues.
  • Experience working cross-functionally with diverse stakeholders.
  • Ability to evaluate the impact of key Regulatory Intelligence on disease area and project strategy
  • Have knowledge about Regulatory Intelligence Tools and stays current with Regulatory news regarding key competitors and the disease area.
  • Have expert knowledge of US and European Regulatory Affairs and an understanding of the broader regulatory ecosystem.

Desirables for the role

  • A good understanding of the commercial aspects of drug development
  • Experience in relevant therapy area (small molecules & biologics) is preferred.
  • Critical thinking on current global regulatory science trends and questions with a good understanding of the corresponding scientific and clinical components.
  • Ability to help inform regulatory strategy and key drug development decisions.
  • Experience developing internal processes, infrastructure to support regulatory intelligence needs, such as SharePoint sites, libraries, web pages, etc.
  • Strong organizational skills.

Why AstraZeneca?

Because innovation is at our heart, we’re championing a new mindset for Regulatory. Shifting from conservative to progressive, we look beyond spotting risks, to being solution-oriented. We are pro-actively involved in the strategy, changing the course for approvals and influencing regulators on new technology.

Our science-driven approach means our Regulatory strategy is even more appreciated and valued. Here we get to be part of the solution, bringing lifechanging medicines to patients.

We are eager to know more about you. If you are interested to know more about us, apply now!

Applications open on January 27, 2022 and we welcome your CV and cover letter no later than March 31st, 2022.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

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